City of Hope Comprehensive Cancer Center, Los Angeles, CA, USA.
Analysis Group, Inc., Los Angeles, CA, USA.
Adv Ther. 2019 Oct;36(10):2783-2796. doi: 10.1007/s12325-019-01060-y. Epub 2019 Aug 22.
Nivolumab has been approved in patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting. A pivotal trial compared nivolumab with ipilimumab; however, no head-to-head trial exists comparing nivolumab to observation, a common comparator in the adjuvant setting. Here, we compared the efficacy and cost-effectiveness of nivolumab with observation or ipilimumab as adjuvant therapies in resected stage IIIB/C melanoma.
Patient data were pooled from the EORTC 18071 and CheckMate 238 trials using propensity score weighting and adjusting for cross-trial differences. Number needed to treat (NNT) and costs per recurrence-free life-month (RFLM) at 12, 16, 18, and 24 months (as data allowed) were estimated. Costs included drug acquisition, administration costs, and direct medical costs. Sensitivity analyses including patients with stage IIIB/C and resected stage IV melanoma were conducted.
A total of 1287 patients (278 nivolumab, 365 observation, and 644 ipilimumab) with resected stage IIIB/C melanoma were pooled. NNTs to achieve one additional recurrence-free survivor with nivolumab versus observation were 3.93 at 12 months and 3.42 at 24 months; NNTs for nivolumab versus ipilimumab were 7.97 at 12 months and 6.43 at 24 months. Mean drug costs per RFLM were lower for nivolumab at 12, 18, and 24 months, respectively (nivolumab: $13,447, $9462, and $7370; ipilimumab: $52,734, $40,484, and $33,875). Mean medical costs per RFLM were the lowest for nivolumab versus observation or ipilimumab at 12 months ($449 versus $674 or $1531) and 16 months ($383 versus $808 or $1316). The sensitivity analysis results were consistent with the base case.
For resected melanoma, adjuvant nivolumab is both clinically effective and cost-effective compared with observation or ipilimumab. Adjuvant nivolumab was associated with a lower drug cost per RFLM compared with ipilimumab, and a lower medical cost compared with observation. Future analyses incorporating long-term follow-up data may help increase understanding of the economic impact of nivolumab in the adjuvant setting.
Bristol-Myers Squibb Company.
纳武利尤单抗已被批准用于接受完全切除术的伴有淋巴结受累或转移性疾病的黑色素瘤患者，适用于辅助治疗。一项关键试验比较了纳武利尤单抗与伊匹单抗；然而，在辅助治疗中，尚不存在纳武利尤单抗与观察比较的头对头试验，观察是一种常见的对照。在此，我们比较了纳武利尤单抗与观察或伊匹单抗作为 IIIB/C 期黑色素瘤切除后的辅助治疗的疗效和成本效益。
使用倾向评分加权和调整跨试验差异的方法，从 EORTC 18071 和 CheckMate 238 试验中汇总患者数据。在 12、16、18 和 24 个月（如数据允许）时，估计了需要治疗的人数（NNT）和每无复发生存月（RFLM）的成本（无复发生存月数是指从治疗开始至肿瘤复发或任何原因死亡的时间）。成本包括药物获取、管理成本和直接医疗成本。进行了包括 IIIB/C 期和切除的 IV 期黑色素瘤患者的敏感性分析。
共纳入 1287 例（278 例纳武利尤单抗、365 例观察、644 例伊匹单抗）接受 IIIB/C 期黑色素瘤切除术的患者。纳武利尤单抗与观察相比，每增加一个无复发生存者的 NNT 分别为 12 个月时 3.93 和 24 个月时 3.42；纳武利尤单抗与伊匹单抗相比，NNT 分别为 12 个月时 7.97 和 24 个月时 6.43。12、18 和 24 个月时，纳武利尤单抗每无复发生存月的药物成本分别较低（纳武利尤单抗：13447 美元、9462 美元和 7370 美元；伊匹单抗：52734 美元、40484 美元和 33875 美元）。12 个月（449 美元 vs 674 美元或 1531 美元）和 16 个月（383 美元 vs 808 美元或 1316 美元）时，纳武利尤单抗与观察或伊匹单抗相比，每无复发生存月的医疗成本最低。敏感性分析结果与基础情况一致。
对于切除的黑色素瘤，与观察或伊匹单抗相比，辅助使用纳武利尤单抗具有临床疗效和成本效益。与伊匹单抗相比，纳武利尤单抗的每无复发生存月药物成本较低，与观察相比，医疗成本较低。未来结合长期随访数据的分析可能有助于提高对纳武利尤单抗在辅助治疗中的经济影响的理解。
百时美施贵宝公司。
